Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms (RUBIN)

January 26, 2026 updated by: iOMEDICO AG

Clinical Research Platform on Treatment, Quality of Life and Outcome of Patients With Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms

The purpose of the project is to set up a national, prospective, longitudinal, multicenter registry platform to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with hematological malignancies in Germany.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

RUBIN is a national, observational, prospective, longitudinal, multicenter registry platform with the purpose to record information on the antineoplastic treatment of hematological malignancies in Germany.

It will identify common therapeutic sequences and changes in the treatment of the disease, and will analyse the impact of novel treatments on the outcome of patients in routine care. Unmet needs and areas with the potential for improvement in routine care are to be identified.

At inclusion, data in patient characteristics, comorbidities, clinical characteristics and previous treatments, if applicable, are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and clinical outcome are documented.

Health-realted quality of life in patients with hematological malignancies will be evaluated for up to one year.

Study Type

Observational

Enrollment (Estimated)

2950

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Freiburg im Breisgau, Germany
        • Recruiting
        • Praxis für Interdisziplinäre Hämatologie und Onkologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult patients with hematologic malignancies requiring systemic treatment

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Confirmed diagnosis of the respective NHL

  • If patient is alive: signed written informed consent

    • For patients participating in the PRO survey: IC prior to or at day of start of respective line of treatment.
    • For patients not participating in the PRO survey: IC latest eight weeks after start of respective line of treatment.

Exclusion Criteria:

  • No systemic therapy for respective lymphoid malignancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Chronic Lymphocytic Leukemia (CLL)
Patients with CLL receiving systemic treatment (physician's choice)
Other: Routine care as per site standard.
Physician's choice according to patient's needs.
Diffuse Large B-cell Lymphoma (DLBCL)
Patients with DLBCL receiving systemic treatment (physician's choice)
Other: Routine care as per site standard.
Physician's choice according to patient's needs.
Follicular Lymphoma (FL)
Patients with FL receiving systemic treatment (physician's choice)
Other: Routine care as per site standard.
Physician's choice according to patient's needs.
Mantle Cell Lymphoma (MCL)
Patients with MCL receiving systemic treatment (physician's choice)
Other: Routine care as per site standard.
Physician's choice according to patient's needs.
Marginal Zone Lymphoma (MZL)
Patients with MZL receiving systemic treatment (physician's choice)
Other: Routine care as per site standard.
Physician's choice according to patient's needs.
Waldenström's macroglobulinemia (WM)
Patients with WM receiving systemic treatment (physician's choice)
Other: Routine care as per site standard.
Physician's choice according to patient's needs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Course of treatment (treatment reality)
Time Frame: 5 years
Documentation of anamnestic data and therapy sequences. Documentation of anamnestic data and therapy sequences
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Response
Time Frame: 5 years
Documentation of response rates per line of treatment.
5 years
Progression-free survival
Time Frame: 5 years
Documentation of progression-free survival per line of treatment.
5 years
Overall survival
Time Frame: 5 years
Documentation of overall survival time.
5 years
Health-related quality of life (Patient-reported outcome)
Time Frame: 1 year
EORTC QLQ-C30 core questionnaire
1 year
Disease-specific quality of life (Patient-reported outcome, patients with CLL)
Time Frame: 1 year
EORTC QLQ-CLL17
1 year
Disease-specific quality of life (Patient-reported outcome, patients with LG-NHL)
Time Frame: 1 year
EORTC QLQ-NHL-LG20
1 year
Disease-specific quality of life (Patient-reported outcome, patients with HG-NHL)
Time Frame: 1 year
EORTC QLQ-NHL-HG29
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

iOMEDICO AG

Investigators

  • Study Chair: Rainer Claus, Prof. Dr., Universitätsklinikum Augsburg, Germany
  • Study Chair: Tobias Dechow, Studienzentrum Onkologie Ravensburg, Germany
  • Study Chair: Paul Graf La Rosée, Prof. Dr., Schwarzwald-Baar Klinikum, Germany
  • Study Chair: Jens Kisro, Dr., Lübecker Onkologische Schwerpunktpraxis, Germany
  • Study Chair: Patrick Marschner, Dr., Praxis für Interdisziplinäre Hämatologie und Onkologie, Freiburg, Germany
  • Study Chair: Ingo Tamm, PD Dr., Onkologische Schwerpunktpraxis Kurfürstendamm, Berlin, Germany
  • Study Chair: Robert Zeiser, Prof. Dr., Universitätsklinikum Freiburg, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2023

Primary Completion (Estimated)

December 1, 2033

Study Completion (Estimated)

December 1, 2033

Study Registration Dates

First Submitted

September 1, 2023

First Submitted That Met QC Criteria

September 15, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iOM-080485

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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